Respiratory Syncytial Virus Infections Clinical Trial
Official title:
A Multi-Center, Outpatient, Surveillance Study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus-related Hospitalizations Among Subjects < 24 Months of Age With a Medically Attended Respiratory Tract Infection
The purpose of this study is to collect clinical outcome and nasal viral load information.
There is no vaccine available to prevent Respiratory Syncytial Virus disease; however, a
humanized monoclonal antibody is approved for the prevention of Respiratory Syncytial Virus
infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital
heart disease, and chronic lung disease). Beyond this high-risk group, infection is common
in otherwise healthy infants and can be severe, leading to hospitalization and while
uncommon, death. Each year in the United States, approximately 100,000 Respiratory Syncytial
Virus-related hospitalizations occur in low risk infants. Currently, treatment of infants
suffering from Respiratory Syncytial Virus disease is limited to supportive care with the
goal of maintaining adequate oxygenation and nutrition.
The availability of a novel anti-Respiratory Syncytial Virus therapeutic that reduces the
number of hospitalizations related to Respiratory Syncytial Virus infection would fulfill an
unmet medical need in the pediatric population. For maximum effect, such a treatment should
be administered as early as possible in the course of infection. Accordingly, the
opportunities for early intervention with an anti-Respiratory Syncytial Virus therapeutic
are in the outpatient setting, prior to hospitalization. However, the incidence of
Respiratory Syncytial Virus-related hospitalization, as well as the natural history and
viral dynamics of Respiratory Syncytial Virus infection, remain undefined in the outpatient
setting. A better understanding of the prevalence of Respiratory Syncytial Virus infection
and subsequent hospitalization rates among symptomatic infants as well as the early disease
course of Respiratory Syncytial Virus infection will help in the design of clinical trials
needed to assess the efficacy of an anti-Respiratory Syncytial Virus therapeutic developed
by Gilead Sciences.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03698084 -
RESCEU: Defining the Burden of RSV Disease
|
||
| Completed |
NCT04090658 -
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
|
Phase 1 | |
| Completed |
NCT04231968 -
A Study of AK0529 in Chinese Infants Hospitalized With RSV
|
Phase 3 | |
| Completed |
NCT03227029 -
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
| Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
| Withdrawn |
NCT02864628 -
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
|
Phase 1 | |
| Terminated |
NCT02948127 -
Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
| Completed |
NCT02873286 -
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
|
Phase 2 | |
| Completed |
NCT02237209 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT02040831 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT02247726 -
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
|
Phase 2 | |
| Completed |
NCT01915394 -
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)
|
N/A | |
| Completed |
NCT01355016 -
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00232635 -
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
|
Phase 2 | |
| Completed |
NCT01155193 -
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
|
||
| Not yet recruiting |
NCT06083623 -
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
|
Phase 2/Phase 3 | |
| Terminated |
NCT02890381 -
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
| Active, not recruiting |
NCT03422237 -
Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
| Completed |
NCT03674177 -
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
|
Phase 1 | |
| Completed |
NCT01968083 -
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 |